PLYMOUTH MEETING, Pa.,
Dec. 3, 2020 /PRNewswire/ -- INOVIO
(NASDAQ:INO), a biotechnology company focused on bringing to market
precisely designed DNA medicines to treat and protect people from
infectious diseases and cancer, today announced the execution of an
agreement with Kaneka Eurogentec S.A., an affiliate of Kaneka
Corporation, for Eurogentec to manufacture INOVIO's COVID-19
vaccine candidate INO-4800 at their industry-leading GMP plasmid
production scales. Terms of the agreement were not disclosed.
Kaneka Eurogentec joins existing partners Thermo Fisher
Scientific, Richter-Helm BioLogics and Ology Biosciences in
INOVIO's global manufacturing consortium. Each contract development
and manufacturing organization that has been selected to join the
consortium is compliant with commercial GMP standards and capable
of supporting INOVIO's future large-scale global manufacturing
needs across its portfolio of DNA medicines and vaccines.
INOVIO's President & CEO, Dr. J.
Joseph Kim, said, "Our partnership with Kaneka Eurogentec,
one of the world's largest and most experienced plasmid
manufacturers, provides additional scale to our growing global
manufacturing coalition. Kaneka Eurogentec will be a crucial member
of INOVIO's global manufacturing consortium, supporting our plans
to produce, manufacture and scale our COVID-19 vaccine candidate,
INO-4800."
Dr. Lieven Janssens, Kaneka
Eurogentec's President and CEO, said, "We are excited to join
INOVIO's growing global manufacturing consortium and look forward
to supporting the manufacturing needs of DNA medicines and vaccines
across INOVIO's platform. We are pleased that our large-scale
manufacturing technologies are well-recognized by INOVIO, a leading
player in the DNA plasmid field."
INOVIO's Senior Vice President of Biological Manufacturing and
Clinical Supply Management, Robert J. Juba
Jr., said, "Kaneka Eurogentec brings a wealth of DNA plasmid
manufacturing expertise and innovation to INOVIO's global
consortium to manufacture INO-4800. We look forward to working with
them to utilize their state-of-the-art, large-scale manufacturing
capabilities towards our goal of producing hundreds of millions of
doses of INO-4800 for worldwide distribution."
INOVIO recognizes the importance of having a robust coalition to
support its broader development platform for DNA medicines as well
as its COVID-19 vaccine candidate, INO-4800. As a result, the
company continues to build the coalition to ensure timely,
cost-effective and scalable production of DNA medicines and
vaccines. INOVIO's third-party manufacturers will produce the
patent-protected formulation for INO-4800, developed to enhance
stability of the vaccine with a favorable tolerability profile.
Importantly, INO-4800 has shown an excellent thermo-stability
profile. INOVIO's other platform DNA vaccine candidates have also
demonstrated a shelf life of greater than 5 years when refrigerated
and stability for more than 30 days at 37 degrees Celsius, and more
than one year at room temperature. INOVIO's candidates also do not
need to be frozen during transport or storage, a vital factor when
implementing immunizations on a global scale. INO-4800 is
administered via INOVIO's proprietary CELLECTRA® smart delivery
device, which delivers the vaccine locally into the patient's skin,
a process that takes only a few seconds.
INOVIO is conducting a Phase 2 segment of its planned Phase 2/3
clinical trial for INO-4800, its COVID-19 vaccine candidate. The
planned Phase 2/3 clinical trial, called INNOVATE (INovio INO-4800
Vaccine Trial for Efficacy), is a randomized, blinded,
placebo-controlled safety and efficacy trial of INO-4800 to be
conducted in adults in the U.S. The INNOVATE trial will be funded
by the U.S. Department of Defense (DoD) Joint Program Executive
Office for Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRND) in coordination with the Office of the Assistant
Secretary of Defense for Health Affairs (OASD (HA)) and the Defense
Health Agency (DHA).
The DoD has agreed to provide funding for both the Phase 2 and
Phase 3 segments of the INNOVATE clinical trial, in addition to the
$71 million of funding previously
announced in June for the large-scale manufacture of the company's
proprietary smart device CELLECTRA® 3PSP and the procurement of
CELLECTRA® 2000 devices.
About the INO-4800 "INNOVATE" Phase 2/3 Clinical
Trial
The lead Principal Investigator for the INNOVATE trial is Dr.
Pablo Tebas, Professor of Medicine
at the Hospital of the University of
Pennsylvania. The Phase 2 segment of the trial is designed
to evaluate safety, tolerability and immunogenicity of INO-4800 in
a 2-dose regimen (1.0 mg or 2.0 mg), in a three-to-one
randomization to receive either INO-4800 or placebo for each dose,
to confirm the more appropriate dose(s) for each of three age
groups (18-50 years, 51-64 years and 65 years and older) for the
subsequent Phase 3 efficacy evaluation. The company intends to work
diligently to ensure diversity in enrollment, targeting specific
populations that are working or residing in environments with high
infection rates and/or areas where there is greater risk of
exposure to SARS-CoV-2, for whom exposure may be relatively
prolonged or for whom personal protective equipment (PPE) may be
inconsistently used, especially in confined settings.
In the Phase 3 segment of the trial, INOVIO intends to enroll
healthy men and non-pregnant women 18 years and older, to evaluate
the efficacy of the proposed dose(s) based on the data from the
Phase 2 evaluation. Participants will be enrolled in a
one-to-one randomization to receive either INO-4800 or a placebo.
The Phase 3 segment will be case-driven with the final number of
enrollees to be determined by the incidence of COVID-19 during the
Phase 3 segment. The primary endpoint of the Phase 3 segment will
be virologically-confirmed COVID-19 disease.
About INOVIO's Global Coalition Advancing INO-4800
INOVIO has assembled a global coalition of collaborators,
partners and funders to rapidly advance the development of
INO-4800. R&D collaborators to date include the Wistar
Institute, the University of
Pennsylvania, the University of
Texas, Fudan University and Laval
University. INOVIO has partnered with Advaccine and the
International Vaccine Institute to conduct clinical trials of
INO-4800 in China and South Korea, respectively. INOVIO is also
assessing nonclinical efficacy of INO-4800 in several animal
challenge models with Public Health England (PHE) and Commonwealth
Scientific and Industrial Research Organization (CSIRO) in
Australia. INOVIO is working with
a team of contract manufacturers including Kaneka Eurogentec,
Thermo Fisher Scientific, Richter-Helm BioLogics, and Ology
Bioservices to manufacture INO-4800 on a commercial scale and is
seeking additional external funding and partnerships to further
scale up manufacturing capacities to satisfy the urgent global
demand for safe and effective vaccines. To date, the Coalition for
Epidemic Preparedness Innovations (CEPI), the Bill & Melinda
Gates Foundation, and the U.S. Department of Defense have
contributed significant funding to the advancement and
manufacturing of INO-4800.
About INO-4800
INO-4800 is INOVIO's DNA vaccine candidate intended to protect
against SARS-CoV-2, the novel coronavirus that causes COVID-19.
INOVIO has extensive experience working with coronaviruses and was
the first company to initiate a Phase 2a trial for INO-4700, a
vaccine for Middle East Respiratory Syndrome (MERS), another
coronavirus related to SARS-CoV-2.
INO-4800 is the only nucleic-acid based vaccine that is stable
at room temperature for more than a year and does not need to be
frozen in transport of storage, which are important factors when
implementing mass immunizations.
About INOVIO's DNA Medicines Platform
INOVIO has 15 DNA medicine clinical programs currently in
development focused on HPV-associated diseases, cancer, and
infectious diseases, including coronaviruses associated with MERS
and COVID-19 diseases being developed under grants from the
Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S.
Department of Defense. DNA medicines are composed of optimized DNA
plasmids, which are small circles of double-stranded DNA that are
synthesized or reorganized by a computer sequencing technology and
designed to produce a specific immune response in the body.
INOVIO's DNA medicines deliver optimized plasmids directly into
cells intramuscularly or intradermally using INOVIO's proprietary
hand-held smart device called CELLECTRA®. The CELLECTRA device uses
a brief electrical pulse to reversibly open small pores in the cell
to allow the plasmids to enter, overcoming a key limitation of
other DNA and other nucleic acid approaches, such as mRNA. Once
inside the cell, the DNA plasmids enable the cell to produce the
targeted antigen. The antigen is processed naturally in the cell
and triggers the desired T cell and antibody-mediated immune
responses. Administration with the CELLECTRA device ensures that
the DNA medicine is efficiently delivered directly into the body's
cells, where it can go to work to drive an immune response.
INOVIO's DNA medicines do not interfere with or change in any way
an individual's own DNA. The advantages of INOVIO's DNA medicine
platform are how fast DNA medicines can be designed and
manufactured; the stability of the products, which do not require
freezing in storage and transport; and the robust immune response,
safety profile, and tolerability that have been observed in
clinical trials.
With more than 2,000 patients receiving INOVIO investigational
DNA medicines in more than 7,000 applications across a range of
clinical trials, INOVIO has a strong track record of rapidly
generating DNA medicine candidates with potential to meet urgent
global health needs.
About Kaneka Eurogentec
Eurogentec was founded in 1985 as a spin-off of the University
of Liège (Belgium). Kaneka
Eurogentec contributes to improving health and fighting diseases by
supplying products and services to scientists involved in life
science research, molecular diagnostics, and therapeutic
developments. The Liège-based company is recognized as one of the
major suppliers in the field of genomics and proteomics as well as
a trusted US FDA inspected Contract Development and Manufacturing
Organization (CDMO) for the bio-production of pharmaceuticals
vaccines and medicines. Kaneka Eurogentec is a leading company in
large scale production of GMP DNA Plasmid for DNA vaccines and
starting materials for vector-based gene medicines. In parallel,
Kaneka Eurogentec offers CDMO services for GMP mRNA, the active
molecule of RNA vaccines and RNA based gene therapy. In 2010,
Eurogentec, renamed Kaneka Eurogentec in April 2017, became part of Kaneka Corporation, a
large Japanese chemical company focusing on technology and
innovation. For more information, visit
https://www.eurogentec.com/
About INOVIO
INOVIO is a biotechnology company focused on rapidly bringing to
market precisely designed DNA medicines to treat and protect people
from infectious diseases, cancer, and diseases associated with HPV.
INOVIO is the first and only company to have clinically
demonstrated that a DNA medicine can be delivered directly into
cells in the body via a proprietary smart device to produce a
robust and tolerable immune response. Specifically, INOVIO's lead
candidate VGX-3100, currently in Phase 3 trials for precancerous
cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18
in a Phase 2b clinical trial.
High-risk HPV is responsible for 70% of cervical cancer, 91% of
anal cancer, and 69% of vulvar cancer. Also in development are
programs targeting HPV-related cancers and a rare HPV-related
disease, recurrent respiratory papillomatosis (RRP);
non-HPV-related cancers glioblastoma multiforme (GBM) and prostate
cancer; as well as externally funded infectious disease DNA vaccine
development programs in Zika, Lassa fever, Ebola, HIV, and
coronaviruses associated with MERS and COVID-19 diseases. Partners
and collaborators include Advaccine, ApolloBio Corporation,
AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for
Epidemic Preparedness Innovations (CEPI), Defense Advanced Research
Projects Agency (DARPA)/Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRND)/Department of Defense (DOD), HIV Vaccines Trial
Network, International Vaccine Institute (IVI), Kaneka Eurogentec,
Medical CBRN Defense Consortium (MCDC), National Cancer Institute,
National Institutes of Health, National Institute of Allergy and
Infectious Diseases, Ology Bioservices, the Parker Institute for
Cancer Immunotherapy, Plumbline Life Sciences, Regeneron,
Richter-Helm BioLogics, Thermo Fisher Scientific, University of Pennsylvania, Walter Reed Army
Institute of Research, and The Wistar Institute. INOVIO also is a
proud recipient of 2020 Women on Boards "W" designation recognizing
companies with more than 20% women on their board of directors. For
more information, visit www.inovio.com.
CONTACTS:
Media: Jeff Richardson,
267-440-4211, jrichardson@inovio.com
Investors: Ben Matone, 484-362-0076,
ben.matone@inovio.com
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
and manufacture DNA medicines, our expectations regarding our
research and development programs, including the planned initiation
and conduct of the Phase 2/3 clinical trial of INO-4800, and our
ability to successfully manufacture and produce large quantities of
our product candidates if they receive regulatory approval. Actual
events or results may differ from the expectations set forth herein
as a result of a number of factors, including uncertainties
inherent in preclinical studies, clinical trials, product
development programs and commercialization activities and outcomes,
our ability to secure sufficient manufacturing capacity to mass
produce our product candidates, the availability of funding to
support continuing research and studies in an effort to prove
safety and efficacy of electroporation technology as a delivery
mechanism or develop viable DNA medicines, our ability to support
our pipeline of DNA medicine products, the ability of our
collaborators to attain development and commercial milestones for
products we license and product sales that will enable us to
receive future payments and royalties, the adequacy of our capital
resources, the availability or potential availability of
alternative therapies or treatments for the conditions targeted by
us or our collaborators, including alternatives that may be more
efficacious or cost effective than any therapy or treatment that we
and our collaborators hope to develop, issues involving product
liability, issues involving patents and whether they or licenses to
them will provide us with meaningful protection from others using
the covered technologies, whether such proprietary rights are
enforceable or defensible or infringe or allegedly infringe on
rights of others or can withstand claims of invalidity and whether
we can finance or devote other significant resources that may be
necessary to prosecute, protect or defend them, the level of
corporate expenditures, assessments of our technology by potential
corporate or other partners or collaborators, capital market
conditions, the impact of government healthcare proposals and other
factors set forth in our Annual Report on Form 10-K for the year
ended December 31, 2019, our
Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and other filings we make from
time to time with the Securities and Exchange Commission. There can
be no assurance that any product candidate in our pipeline will be
successfully developed, manufactured or commercialized, that final
results of clinical trials will be supportive of regulatory
approvals required to market products, or that any of the
forward-looking information provided herein will be proven
accurate. Forward-looking statements speak only as of the date of
this release, and we undertake no obligation to update or revise
these statements, except as may be required by law.
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SOURCE INOVIO Pharmaceuticals, Inc.